The present invention relates to topical formulations useful for treating fungal diseases, canidiasis, intertriginous dermatitis and their related inflammation. In particular, the present invention relates to stable topical formulations containing an antifungal agent and an anti-inflammatory steroid.
Currently, there is no topical dermatologic preparation that is appropriate for almost all of the skin conditions that are normally seen by pediatricians, internists, and dermatologists. Various formulations based on combinations of anti-fungals and steroids are described in U.S. Pat. Nos. 4,912,124, 5,002,938, 5,021,458, 5,110,809, 5,174,475, 5,219,877, 5,407,663, 5,310,545, 6,075,056, and 6,080,744. The disadvantage of such combinations is that it is undesirable to use fluorinated and/or potent steroids for topical treatment for extended periods of time. Steroids can penetrate the skin and cause undesirable side effects, including skin atrophy, hypopigmentation, suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome, and appearance of telangectasias.
Several formulations that are commercially available include Lotrisone™ cream (clotrimazole 1%/betamethasone dipropionate 0.064%), Daktacort™ cream (miconazole nitrate 2%/hydrocortisone 1%) and Canesten™ HC cream (clotrimazole 1%/hydrocortisone 1%). The steroid component, betamethasone dipropionate, Lotrisone™, is so strong that it can induce skin atrophy, striae, persistent tinea corporis and even growth retardation in children receiving Lotrisone™ treatment (see, for example, Pediatr. Dermatol. 19(1):78-81 (2002); Cutis 69(1):67-68 (2002); Am. Fam. Physician 65(10:2095-2102 (2002)). The remaining two products have only 1% hydrocortisone, which is too low in potency to have significant anti-inflammatory properties.
Therefore, there is no need for a dermatologic formulation that will cause reduced side effects but will still be potent enough for efficacy.